P60 Program Project Grant-Outreach for Smoke-Free Homes

• ClinicalTrials.gov Identifier: NCT01574560
• Recruitment Status: Completed
• First Posted: April 10, 2012
• Last Update Posted: August 6, 2014
• Sponsor: University of Minnesota
• Information provided by (Responsible Party): University of Minnesota

Tracking Information

• First Submitted Date: April 5, 2012
• First Posted Date: April 10, 2012
• Last Update Posted Date: August 6, 2014
• Study Start Date: January 2011
• Actual Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 5, 2012)

Change in Home Secondhand Smoke levels [ Time Frame: From Baseline to Week 26 Follow-Up ]

Measured by nicotine dosimeter - a passive "badge" hung in the home that measures free floating airborne nicotine particles.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 25, 2012)

• Comparison of Child Cotinine Levels in Urine [ Time Frame: From Baseline to Week 26 Follow-Up ]
  Cotinine is an alkaloid found in tobacco and is also a metabolite of nicotine. Cotinine is used as a biomarker for exposure to tobacco smoke. Child (non-smoker) cotinine will be used as an objective measure of secondhand smoke exposure at baseline and again at end of study (week 26).
• Comparison of Questionnaire Results [ Time Frame: Baseline, Week 16 and Week 26 ]
  Measured by mediators and moderators of effect, including psychosocial and tobacco-related variables.

Original Secondary Outcome Measures (submitted: April 5, 2012)

• Comparison of Cotinine Levels in Urine [ Time Frame: From Baseline to Week 26 Follow-Up ]
  Cotinine is an alkaloid found in tobacco and is also a metabolite of nicotine. Cotinine is used as a biomarker for exposure to tobacco smoke. Cotinine levels <10 ng/mL are considered to be consistent with no active smoking. Values of 10 ng/mL to 100 ng/mL are associated with light smoking or moderate passive exposure, and levels above 300 ng/mL are seen in heavy smokers - more than 20 cigarettes a day. In urine, values between 11 ng/mL and 30 ng/mL may be associated with light smoking or passive exposure, and levels in active smokers typically reach 500 ng/mL or more.
• Comparison of Questionnaire Results [ Time Frame: Baseline, Week 16 and Week 26 ]
  Measured by mediators and moderators of effect, including psychosocial and tobacco-related variables.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: P60 Program Project Grant-Outreach for Smoke-Free Homes
• Official Title: Community Outreach and Biomarker Feedback for Smoke-Free Homes
• Brief Summary: Smoking is widely accepted to cause an increase in an individual's likelihood of developing cancer and heart disease. The effects of tobacco smoke are not limited to smokers. Secondhand smoke inhaled by a non-smoker has also been associated with the development of several illnesses. This study focuses on learning how to make your home smoke-free.

Detailed Description

This study will be conducted in two phases. Phase 1 will be qualitative focus groups/pilot study with the purpose to develop a motivationally enhanced biomarker feedback counseling protocol and all printed materials to be used in Phase 2. After investigators develop a good working treatment protocol, an active intervention in smoking homes who live with a child in their home will be carried out.

Those randomized to the Control Group will receive health education in the form of brochures detailing the health effects of secondhand smoke and how to make their home smoke free. Participants randomized to the Treatment Group will receive tobacco-specific biomarker feedback and personalized motivationally enhanced counseling.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Smoking Cessation
• Tobacco Cessation

Intervention

• Behavioral: Brochure
  Information regarding secondhand smoke and creating a healthy home environment.
• Behavioral: Counseling
  Receives brochure and counseling sessions focusing on changing smoking behaviors and/or other health behaviors.

Study Arms

• Active Comparator: Control Group - Health Education
  This group is provided with information regarding secondhand smoke and creating a healthy home environment.
  Intervention: Behavioral: Brochure
• Active Comparator: Treatment Group - Counseling
  This group is provided with biomarker feedback on child exposure to secondhand smoke. Active participants receive 5 counseling sessions from a trained research counselor; 3 sessions in the home and 2 by phone. The counseling sessions focus on changing smoking behaviors and/or other behaviors that impact smoking.
  Intervention: Behavioral: Counseling

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 3, 2013): 212
• Original Estimated Enrollment (submitted: April 5, 2012): 200
• Actual Study Completion Date: April 2013
• Actual Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria (adult):

• Age 18 years or older
• Female
• Smoked ≥ 1 cigarettes per day for at least the past 6 months
• Smoked on 20 days or more in the last month
• Smoking status confirmed via cotinine verification strips
• Resides with a child ≤ 10 years of age in the role of the child's parent or caregiver
• Will agree to provide a urine sample at study enrollment
• Will also agree to the child providing a urine sample at study enrollment and at follow-up visits (for children who are not toilet trained, a diaper sample will be collected in lieu of the urine sample)
• Has a home address
• Has a functioning home phone or cell phone
• Provides written informed consent

Inclusion criteria (child):

• < or = 10 years of age
• Non-smoker -no cigarette use within prior 30 days to enrollment; however experimentation with smoking (a puff) will not exclude the child
• Lives in the primary home with the adult study participant at least 5 days a week

Exclusion criteria (adult):

• Current or past 7 day use of Nicotine Replacement Therapy (NRT) or pharmacotherapy for smoking cessation
• Planning to move outside of Minnesota within the next 3 months
• Have complete home smoking restrictions currently in place verified by the nicotine dosimeter
• Currently pregnant

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01574560
• Other Study ID Numbers: 2009NTLS058
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of Minnesota
• Study Sponsor: University of Minnesota
• Collaborators: Not Provided

Investigators

• Principal Investigator: Janet L. Thomas, Ph.D.; Masonic Cancer Center, University of Minnesota

• PRS Account: University of Minnesota
• Verification Date: August 2014